Docket Number: FDA-2021-D-1158 Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This guidance also addresses FDA’s recommendations regarding section 524B of the FD&C Act for cyber devices. This document supersedes the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” issued June 27, 2025.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Food and Drug Administration
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All written comments should be identified with this document’s docket number: FDA-2021-D-1158.
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Content current as of:
02/03/2026
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